Kornimate/medical-research-clean huggingface dataset:
open-label c1 esterase inhibitor (c1inh-nf) for the treatment of acute hereditary angioedema (hae) attacks

Conditions: Hereditary Angioedema

Summary: the study objective was to evaluate the safety and efficacy of repeat use of c1inh-nf for the treatment of acute hae attacks.

a total of 113 subjects were enrolled in the study. one-hundred-one (101) subjects received c1inh-nf for the treatment of 1 or more hae attacks and were analyzed for efficacy. the study design also allowed for short-term prophylaxis with c1inh-nf prior to emergency or non-cosmetic surgical or dental procedures, and an additional 12 subjects received c1inh-nf only for this purpose. all 113 subjects were exposed to c1inh-nf and analyzed for safety.

Eligibility criteria:
inclusion criteria: this study was open to all subjects who: * completed participation in levp2005-1/a (nct00289211) and were not participating in levp2005-1/b (nct01005888), any time after the 3-day telephone follow-up * completed participation in levp2005-1/b any time after the final prophylactic therapy in part b * were enrolled but not randomized in levp2005-1/a after part a was closed * were excluded from levp2005-1 for any of the following reasons: * pregnancy or lactation * age less than 6 years * narcotic addiction * presence of anti-c1inh autoantibodies * were not enrolled in levp2005-1 after enrollment in levp2005-1 was closed, under the following circumstances: * had a diagnosis of hae: evidence of a low c4 level plus either a low c1inh antigenic level or a low c1inh functional level, or * had a known hae-causing c1inh mutation, or * had a diagnosis of hae based on a strong family history of hae as determined by the principal investigator exclusion criteria: * history of allergic reaction to c1inh or other blood products * participated in any other investigational drug study within the past 30 days * received blood or a blood product in the past 60 days other than c1inh-nf

Keywords: hereditary angioedema c1 esterase inhibitor (human)
retrospective evaluation of supersaturated oxygen (sso2) therapy clinical utility

Conditions: Acute ST Segment Elevation Myocardial Infarction

Summary: the purpose of this multicenter study is to assess the impact of sso2 treatment on clinical outcomes and left ventricular function in patients following acute st-segment elevation myocardial infarction (stemi).

the therox® downstream® system, which is approved for use in the united states (us) by the food and drug administration (fda) under p170027. the therox® downstream® system consists of three primary components. these include a hardware device called the therox downstream system ("console"), a single-use disposable device called the therox downstream cartridge ("cartridge") and a 5 french, commercially available qualified sso2 infusion coronary delivery catheter ("delivery catheter"). this is a multicenter, retrospective case-control study which will collect data from all stemi patients who received sso2 treatment at participating centers, along with up to 3 matched control patients who did not receive sso2 treatment.

Eligibility criteria:
inclusion criteria: * data from all patients who received sso2 treatment and have completed a minimum of 3 months follow up will be collected at each participating center; there are no other exclusion criteria aside from date of treatment. exclusion criteria: -
improving self-management in adolescents with sickle cell disease

Conditions: Sickle Cell Disease

Summary: the objective of this study is to determine the feasibility and acceptability of scthrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mhealth tool, imanage. the study will also evaluate the initial efficacy of scthrive for increasing behavioral activation (ba) in adolescents with sickle cell disease (scd) ages 13 to 21. the investigators hypothesize that participants in the scthrive group will show greater ba (primary outcome) at post-treatment than the attention control group, and that participants in the scthrive group will continue to show significantly greater ba at the six week follow-up compared to the attention control group. investigators will also explore whether scthrive is associated with greater improvements in self-management behaviors and quality of life (secondary outcome) compared to attention control at the six-week follow-up assessment.

the objective of this study is to determine the feasibility and acceptability of scthrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mhealth tool, imanage. the study will also evaluate the initial efficacy of scthrive for increasing behavioral activation (ba) in adolescents with sickle cell disease (scd) ages 13 to 21.

Eligibility criteria:
inclusion criteria: * patient of cchmc sickle cell clinic. * confirmed diagnosis of scd with ss, sb0thal or sc genotype. * 13-21 years of age. * on or eligible for disease-modifying therapies. * caregiver (or aya \> 18 years) consent that the participant will be the sole user of the tablet, report immediately if it is damaged or lost, return it at the end of the study, and log on to sessions from a private location. exclusion criteria: * another chronic disease (which would complicate measurement of behavioral activation) * non-english-speaking (\<5% of the target population); or * cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation. patients who desire participation but are not eligible will be referred to the scd clinic social worker for assistance with self-management as this is the usual procedure.

Keywords: anemia, sickle cell self care adolescent young adult disease management behavioral activation peer communication
mngs vs culture critically ill patients

Conditions: Sepsis

Summary: mngs is popular in research and recently it has been used clinically to detect microbes in the blood or other secretion in infected patients for quicker ,broad and accurate detection of microbes. in icu ,patients are critically ill and need quicker and accurate antibiotics use to stop the pathologic process. the purpose of this study was to determine whether the positive detection rate of pathogens in patients with sepsis by metagenomic full-targeted detection technology was higher than that in blood culture, and to determine whether the pathogens found in patients with sepsis by metagenomic full-targeted detection technology were important for clinical development. anti-infective regimens can help.

sepsis patients in icu were took blood culture sample and blood sample for mngs test (idseqtm ultra, combing with metagenomics and pathogen/amr/vf probe enrichment). clinicians use their knowledge and experience to decide antibiotics use with the guide of culture results or mngs results. validation with digital droplet pcr assays when metagenomic full-targeted assays identify pathogens not identified in conventional blood cultures the difference between the positive rate of mngs and the positive rate of blood culture were recorded. patient were followed at least 28 days after enrollment or an outcome indicator. possible scenarios for detecting clinical impact were detected. etiology, biochemical indicators, immune function, infection indicator, secondary infection, sofa score and length of stay，outcome were recorded.

Eligibility criteria:
inclusion criteria: age \> 18years admit to icu meet the sepsis 3.0 diagnostic criteria and suspected bloodstream infection, and the diagnosis of sepsis ≤ 24 hours; estimated icu stay ≥ 24 hours; informed consent; exclusion criteria: severe organ dysfunction, expected death within 72 hours; receive palliative care; refuse to participate;

Keywords: next- generation sequencing； blood culture；idseqtm ultra
feasibility and safety of in-bed self-exercise in patients with subacute stroke

Conditions: Stroke

Summary: the goal of this to investigate the feasibility and safety of in-bed self-exercises based on emg-sensor feedback in subacute stroke patients. the main question is feasibility and safety. it aims to answer are: \[pittsburgh rehabilitation participation scale\] \[the number and percentage of participating sessions\] \[the number and percentage of completed sessions\] \[the number and percentage of successful sessions\] \[the mean amplitude of muscle contractions in a session\] \[the duration and percentage of participating sessions during self-exercise\] \[rivermead motor assessment\] \[manual muscle test\] \[brunnstrom stages of motor recovery\] \[fugl meyer assessment of lower extremity\] \[berg balance scale\] \[functional ambulation category\] \[modified rankin scale\] \[modified barthel index\] \[short-form health survery 36 version 2\]

the intervention group is provided with graded exercise using the in-bed self-exercises based on emg-sensor feedback according to muscle strength of the hemiplegic lower extremity and brunnstrom stages of motor recovery in addition to conventional rehabilitation whereas the control group is provided with only conventional rehabilitation.

Eligibility criteria:
inclusion criteria: * 19 years and older * the onset of the stroke is less than 3months ago * lower extremity weakness due to stroke (mmt =\< 4 grade) * modified rankine scale 2-5 points * cognitive ability to follow commands exclusion criteria: * stroke recurrence * other neurological abnormalities (e.g. parkinson's disease). * severely impaired cognition * serious and complex medical conditions(e.g. active cancer) * cardiac pacemaker or other implanted electronic system

Keywords: biofeedback clinical trial electromyography self stroke
safety and efficacy study of betamarc to treat loss of weight and appetite in non-small cell lung cancer

Conditions: Anorexia; Cachexia; Weight Loss; Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to determine whether betamarc is effective in improving the appetite and reversing weight loss in patients with advanced non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * newly diagnosed stage iiib or iv non-resectable nsclc. recurrent disease after resection for earlier stage disease is acceptable as long as patients are at least 6 months from surgery. * treatment plan includes a platinum-based doublet chemotherapy. * ecog 0, 1 or 2. * self-reported loss of body weight or anorexia. * serum c-reactive protein ≥5 mg/l. * life expectancy of at least 6 months. * adequate bone marrow, liver and renal function. * normal serum potassium. * ability to comply with the study requirements and give written informed consent. exclusion criteria: * known physical or functional obstruction of the gastrointestinal tract, malabsorption, intractable vomiting, uncontrollable diarrhea, concurrently receiving tube feeding or parenteral nutrition, or unable to swallow investigational drug product. * concomitant therapy with an appetite stimulant. * history of poorly controlled hypertension or congestive heart failure. * any implanted devices that could interfere with dxa scanning. * prolongation of qt interval. * history of additional risk factors for torsades de pointe. * concomitant therapy with beta-adrenergic receptor antagonists (beta-blockers) or ergot derivatives. * females who are breast feeding, pregnant or of child-bearing potential who are not using adequate birth control. * any second malignancy which might confound the interpretation of safety or efficacy assessments. * any condition which increases the patient's risk for participating in the study.
10 vs.15 mcg norepinephrine bolus in severe maternal hypotension during cesarean delivery

Conditions: Hypotension; Spinal Anesthesia; Cesarean Section

Summary: data regarding the optimum dose of norepinephrine for management of severe maternal hypotension is lacking. a previous report showed that the use of 10-mcg norepinephrine bolus was not superior to the 5-mcg bolus in the management of severe hypotension in addition the incidence of reactive bradycardia and hypertension was comparable in the two doses. therefore, we hypothesize that using a higher dose of norepinephrine (15 mcg) would increase the success rate of management of severe hypotensive episode.

upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). an 18g-cannula will be inserted, and the patients will receive 10 mg metoclopramide. baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval. lactated ringer's solution will be infused at rate of 15 ml/kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at l3-l4 or l4-l5 interspace using 25g spinal needle. after subarachnoid block, mothers will be placed in the supine position with left-lateral tilt. block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at t4. the patient would receive the study drug only if she developed severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) as her first hypotensive episode. the management of the hypotensive episode will be considered successful if the systolic blood pressure is \> 80% of the baseline within 2 mins of the bolus. if the bolus failed, norepinephrine bolus of 5 mcg will be given. any other hypotensive episode (systolic blood pressure \<80% of baseline) will be managed with norepinephrine bolus of 5 mcg. intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by iv atropine bolus (0.5 mg) will be administered. fluid administration will be continued up to a maximum of 1.5 liters. an oxytocin bolus (1 iu) will be delivered over five seconds after delivery then infused at a rate of 2.5-7.5 iu/hour.

Eligibility criteria:
inclusion criteria: * full-term singleton pregnant women * american society of anesthesiologist ii, scheduled for elective cesarean delivery, exclusion criteria: * patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction \< 50%, heart block, and arrhythmias), * hypertensive disorders of pregnancy, * peripartum bleeding, * coagulation disorders (patients with inr \>1.4 and or platelet count \< 80000 /dl) or any contraindication to regional anesthesia, * baseline systolic blood pressure (sbp) \< 100 mmhg
long term prognosis of mri diagnosed partial thickness tears of the rotator cuff

Conditions: Rotator Cuff Tear

Summary: patients diagnosed with partial thickness tears of the rotator cuff are sometimes surgically repaired, while other cases are not. it is unknown how patients fare over time without electing surgical repair and how outcomes differ by type of injury.

we plan to conduct a retrospective cohort study to assemble a research database of all patients with shoulder pain from 1/1/02-12/31/06 presenting at the hershey medical center. participants will be identified using billing codes in the medical records office, with inclusion/exclusion criteria as described above. data extraction will include medical record number, demographic data (age, race/ethnicity, sex, insurance type), pre-fracture functional status, pre-admission residence, medical co-morbidities, prior hospitalization within 30 days, abnormal clinical findings on admission, shoulder score, pain score, range of motion score, type of diagnosis (partial tear, full thickness tear, tendonitis, shoulder pain), occupation, past medical history, physical therapy and duration of physical therapy, cigarette/cigar use, drug use, alcohol use, treatment protocols (anti-inflammatory medication, injections, etc.), and complaints by patient of pain status.

Eligibility criteria:
inclusion criteria: * patients examined at the hershey medical center from 1/1/02-12/31/06 with a documented mri report of a partial thickness tear of the rotator cuff that was treated non-operatively. exclusion criteria: * full thickness tear of the rotator cuff, surgically repaired rotator cuff, and patients who do not fit criteria listed in inclusion criteria.

Keywords: partial thickness rotator cuff
quantitative evaluation of the progression of liver disease, using shearwavetm

Conditions: Liver Disease; Heart Failure

Summary: liver biopsy for the assessment of fibrosis has multiple limitations. liver shearwavetm elastography may provide a non-invasive, fast, and reproducible alternative for the quantitative assessment of liver fibrosis.

to obtain a quantitative evaluation of the progression of liver disease, using shearwavetm elastography measurements obtained with the supersonic imagine aixplorer ultrasound machine. to compare the glomerular filtration rate and the quantitative evaluation of the progression of renal disease, using shearwavetm elastography measurements obtained with the supersonic imagine aixplorer ultrasound machine in post-liver transplantation patients.

Eligibility criteria:
inclusion criteria: * males and females over the age of 18 * patients of liver consultant's of texas dallas office, with chronic liver disease or liver transplant patient seen in liver transplant clinic * patients diagnosed with heart failure exclusion criteria: - any person unable to provide an informed consent

Keywords: heart failure liver failure post liver transplant
post-approval study of percutaneous left atrial appendage closure ( flaac-2 )

Conditions: Atrial Fibrillation

Summary: patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to a stroke or systemic embolism. this risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. percutaneous left atrial appendage closure, is a new interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. this procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that can cause distant embolism. closure of the left atrial appendage avoids long term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke. in 2016, two devices developed for transcutaneous closure of the left atrial appendage (watchman, boston scientific, amplatzer cardiac plug, s. jude medical and its evolution amplatzer amulet) were included in the list of products reimbursable in france. the french national authorities have requested the realization of a register whose objectives will be to evaluate: * the efficiency and safety of implanting devices in france * the type and duration of antithrombotic treatment prescribed after left atrial appendage closure


Eligibility criteria:
inclusion criteria: any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not).ot). exclusion criteria: * refusal of the patient to participate in this study and therefore the use of his data * minor patient

Keywords: atrial fibrillation left atrial septal closure
extension to a study on the efficacy and safety of vildagliptin in combination with metformin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. this is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone. the purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * only patients successfully completing study claf237a2303 are eligible * written informed consent * ability to comply with all study requirements exclusion criteria: * premature discontinuation from claf237a2303 * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
subjects through the application of the mindera kit part 2

Conditions: Psoriasis

Summary: a 16 week study to examine if baseline or on-therapy transcriptomics can be used to help predict selection of medications and provide new therapeutic targets for drug development in psoriasis subjects.


Eligibility criteria:
inclusion criteria 1. subject must have the ability to understand and sign written informed consent. 2. subject must be an adult male or female adult who is ≥ 18 years of age at the time of screening. 3. subject must be diagnosed with psoriasis by either a dermatologist or a rheumatologist, with the affected area of ≥ 2 centimeters in diameter. 4. subjects must be treated with anti-tnf-α (or biosimilar) therapy once enrolled in the study.a two-week period is required to washout of the previous biologic when switching therapies. exclusion criteria 1. subject is unable or unwilling to give written informed consent and/or to comply with study procedures. 2. subject has had usage of topical psoriasis treatments on study lesion within 2 weeks prior to baseline studyvisit and unwilling to washout. 3. subjects currently treated with hydroxychloroquine (plaquenil), unless otherwise approved by sponsor
the efficacy of severe whitening and delayed fading in acetic acid-enhanced endoscopy for diagnosing gastric intestinal metaplasia

Conditions: Gastric Intestinal Metaplasia

Summary: investigators found that the degree and the duration of aceto-whitening differed between gastric intestinal metaplasia(gim) and the surrounding normal mucosa: the area of gim showed a severe degree of aceto whiteness and the whitening continued longer than the surrounding normal mucosa, which investigators called "severe whitening" and "delayed fading", and investigators realized that gim could possibly be diagnosed by using these differences.the aim of this prospective study was to investigate the efficacy of "severe whitening" and "delayed fading" for diagnosing gim.


Eligibility criteria:
inclusion criteria: * long-lasting upper gastrointestinal symptoms (\>15 years) * atrophic gastritis or gim identified at surveillance endoscopy exclusion criteria: * presence of advanced adenocarcinoma in the stomach * presence of acute gastrointestinal bleeding * presence of coagulopathy, uncontrolled impaired renal or liver disease * presence of pregnancy or lactation * presence of allergy to acetic acid * age younger than 18 years or older than 80 years * inability to provide written informed consent.